GENORAY GIX-1 User manual

Intraoral Imaging System
GIX-1
For Veterinary Only
User Manual
UM-603 CE VET
2022.12.09 Document Ver. 1.4
Copyright 2012 by GENORAY Co., Ltd. All Rights Reserved

Preface
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Preface
This manual provides information on the introduction and operation of GIX-1 (hereinafter
“Product”) and is written based on standard specifications. Some contents may differ
depending on the purchased product and specifications, and some contents may be changed
without prior notice to improve product performance.
If you have any questions about this product and manual, please refer to the manufacturer or
vendor information on the back cover of the document and contact the representative.

Copyright
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Copyright
The copyright and intellectual property rights of all the contents and drawings of this manual
are owned by Genoray.
Any use, copying, circulation, or distribution without prior written permission from Genoray is
strictly prohibited.
Copyright 2012 by GENORAY Co., Ltd. All Rights Reserved

Contents
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Contents
Preface .............................................................................................................. 3
Copyright........................................................................................................... 4
Contents ............................................................................................................ 5
1. Overview...................................................................................................... 7
1.1) Overview of the manual ........................................................................................................ 7
1.1.1) Definition of the manual ................................................................................................. 7
1.1.2) Notations in the manual.................................................................................................. 8
1.1.3) Warnings in the manual .................................................................................................. 9
1.1.4) Symbols used in the manual ......................................................................................... 10
1.1.5) Contents of the manual ................................................................................................ 11
1.2) Overview of the product ...................................................................................................... 12
1.2.1) Introduction of the Product ........................................................................................... 12
1.2.2) Purpose of use ............................................................................................................. 12
1.2.3) How to Use the Software .............................................................................................. 12
1.2.4) User information .......................................................................................................... 13
1.2.5) Medical device classification and compliance .................................................................. 15
1.2.6) Labeling....................................................................................................................... 16
2. Safety precautions..................................................................................... 17
2.1) General safety precautions................................................................................................... 17
2.2) Radiation safety precautions ................................................................................................ 18
2.3) Precautions before using ..................................................................................................... 19
2.4) Precautions when using....................................................................................................... 20
2.4.1) Instructions for Cleaning............................................................................................... 23
2.5) Maintenance ....................................................................................................................... 25

Contents
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2.6) Instructions for Storage....................................................................................................... 26
2.6.1) Cases of Breakage due to User's Negligence .................................................................. 28
3. Image Acquisition ..................................................................................... 31
3.1) Image acquisition method ................................................................................................... 31
4. Troubleshooting ........................................................................................ 33
4.1) Solutions for failed image acquisition ................................................................................... 33
4.2) Failure of Image acquisition or Image acquisition without X-ray exposure............................... 33
4.3) How to measure ADC offset and set threshold when X-ray is OFF .......................................... 35
4.4) In case of image acquisition failure during X-ray exposure after raising the ADC offset setting
from the default value................................................................................................................... 42
5. Specifications ............................................................................................ 43
5.1) Intraoral Sensor Specifications............................................................................................. 43
5.2) Intraoral Sensor Usage Environment .................................................................................... 46
Appendix 1. Waste treatment method.......................................................... 47
Appendix 2. Dose information ...................................................................... 49
Appendix 3. Calibration................................................................................. 51
A.3.1) Port-X II ............................................................................................................................. 51
A.3.2) Port-X III............................................................................................................................ 51
A.3.3) Port-X IV (Port-X IVe, ZEN-PX4, ZEN-PX4e)........................................................................... 56
A.3.4) Other Portable Equipment ................................................................................................... 57

1. Overview
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1. Overview
This chapter describes the following: the definition of the manual, notations, warnings,
overview of the device, user information, warnings in the manual, and labels and symbols on
the device.
1.1) Overview of the manual
This section provides information regarding the definition of the manual, notations, warnings,
signs, and the contents of the manual.
1.1.1) Definition of the manual
All the intended user of this manual should read this manual carefully, understand it
thoroughly, and then operate the device. Keep this manual at an easily accessible location so
that you can refer to the manual whenever needed.
This manual is provided together with shipment of the product.
This manual is applicable to the standard product specifications available at the time of
shipping. For this reason, some contents herein may be different from features of the product
delivered to your company.

1. Overview
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1.1.2) Notations in the manual
“Notation” refers to special symbols or rules used in a user’s manual.
This manual uses the following notation to allow the user to easily understand the contents of
the manual.
Item Description
“ ” Used to indicate references.
e.g., Refer to "Chapter 1 ____.”
Bold
Used to indicate items displayed on the GUI, such as menu names
and button names.
e.g., Click the Save button.
> Used to arrange several menu items or buttons in order.
e.g., Click Import > Open button.
Used to classify or organize equivalent items based on specific
conditions.
Used to arrange the steps of a task procedure in order.
Used to describe the names or details of components in an image.
Used to describe the order of actions in an image.

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1.1.3) Warnings in the manual
Warnings in this manual are symbols that are intended to allow the user to easily understand
the severity of personal injury or product damage that may occur during use of the product.
Its color and statement differ depending on the risk level.
This manual defines warning signs as follows to allow the user to easily understand the level
of risk.
Failure to follow instructions marked with this sign may cause an accident or
severe injury. Make sure that the user follows the instructions marked with a
“Warning” sign.
Failure to follow instructions marked with this sign may damage the product
or embedded software or cause data loss. Make sure that the user follows the
instructions marked with a “Caution” sign.
This sign indicates instructions that must be checked by the user. Make sure
that the user checks and follows the instructions marked with a “Notice” sign.
This sign indicates instructions that must be noted by the user.

1. Overview
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1.1.4) Symbols used in the manual
Symbol Description Location
Type-B Applied Part Label
Type-BF Applied Part Label
WEEE Mark Label
Refer to instruction manual Label
Name of Manufacturer and Address Label
Manufactured Date Label
Device Serial Number Label
The CE symbol indicates that this product
complies with the European Directive for Medical
Devices 93/42/ EEC as amended by 2007/47/EC
as a class IIb device.
Label
Manual
Authorized Representative
in the European community Manual
Authorized Representative
in the Swiss community
Label
Manual

1. Overview
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1.1.5) Contents of the manual
This manual is composed of 5 chapters and an Appendix. A brief description of each chapter is
shown below.
Chapter 1. Overview
Provides general information regarding the manual and the product.
Chapter 2. Safety Instructions
Provides information regarding the precautions the user must take for safe use of the
product.
Chapter 3. Image Acquisition
Provides instructions to acquire images from the product.
Chapter 4. Troubleshooting
Provides details on how to troubleshoot problems that occur during the use of the product
how to resolve the troubles.
Chapter 5. Product Specification
Provides the information regarding the standard of the product, its specifications,
dimensions, environment of use, etc.
Appendix
Provides the information regarding the operation of the product.

1. Overview
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1.2) Overview of the product
This section provides an overview of the product, including a brief description, the intended
use, user classification, product labels, and information security.
1.2.1) Introduction of the Product
This product is an Intraoral Sensor to acquire an image for dentistry developed by Genoray
Co., Ltd.
This product acquires the images using portable X-ray devices used by dentistry.
Product type
Model Manufacturer
GENORAY
GIX-1
PortView
(Size 1)
GIX-1
PortView
(Size 2)
E2V
EV71JU215
(Size 1)
EV71JU213
(Size 2)
1.2.2) Purpose of use
This product is intended to acquire digital X-ray images of the patients for dentistry.
Do not use this product for any other purpose.
1.2.3) How to Use the Software
For detailed instruction on how to use the software, refer to the Software Manual.

1. Overview
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1.2.4) User information
User classification
GENORAY classifies users as follows, depending on the scope of the product operation and
use:
Type Scope
Operator
Refers to the users that operate the product to acquire images.
Professionals that acquire and review images
Veterinarian or radiologists
Product
administrator
Refers to the users that perform regular inspection and other
maintenance of the product hardware and software.
Medical or imaging professionals that perform quality assurance
tests
Service manager
Refers to the service technicians of GENORAY that perform technical
services on the product
, including failure diagnosis, module repair, and
component replacement.
Maintenance staff that perform maintenance of the product, such
as installation, configuration, setup, and calibration
Do not perform what is not permitted for the user role category you belong
to.
User requirements
The product users require an understand and/or qualifications following items:
Item Requirement
Education Veterinarian’s license, radiologist’s license, or equivalent license (national
license) or degree in the field.
Knowledge
Understanding of the veterinary diagnosis and treatment
Understanding of the terminology and instructions regarding the diagnostic
medical X-ray device
Understanding of the installation, operation, and configuration of the
product
Capability to diagnose using the diagnostic medical X-ray device
Understanding of the purpose and the effect of the treatment
Language Capability to read and understand the manual written in Korean, English, or
other language.

1. Overview
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Training program
GENORAY Co., Ltd. takes no responsibility for any damage or accidents caused due to
inappropriate operation of the product.
Every user should be trained on the usage instruction of the product before
using it. The user should contact the manufacturer or the vendor for more
information regarding usage training.

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1.2.5) Medical device classification and compliance
This section provides information regarding the class of the device and the standard of
compliance.
Conformity notified for medical device
Good Manufacturing Practice
Common Standards for Electrical and Mechanical Safety of Medical Device
Common Standards for Electromagnetic Safety of Medical Device
Standards for Medical Device [Attachment 2] appliance and machinery 56. Diagnostic X-ray
Device
Medical device classification
Item Description
Protection against electric shock
Class I medical device
Type B applied part
Type BF applied part
Standards and regulations
This device is designed and developed in compliance with the following international standards
and regulations:
Standard No.
IEC / EN
IEC / EN 60601-1
IEC / EN 60601-2
IEC / EN 60601-3
IEC / EN 60601-2-45

1. Overview
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1.2.6) Labeling

2. Safety precautions
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2. Safety precautions
This chapter lists the precautions and the types of safety products inside the product that the
user must know to ensure safe use of the product, and provides details on how to operate and
check the safety products.
2.1) General safety precautions
The following are the precautions regarding general risk factors that must be taken:
If any abnormality is found on a body part of a patient that came in contact
with the product, immediately provide the patient with guidance on how to
consult a dermatologist.
Be cautious and ensure that clothing, accessories, or other objects are put
near the product.
Do not store the product in a humid environment or near liquids.
Keep an eye on the patient's condition when acquiring images.
If the patient or product shows any sign of abnormality, immediately stop
operation of the product to ensure safety.
Ensure that any accessory or component of the product is not put around
the area of X-ray exposure.
This product is not appropriate to be used in a location where there is
flammable anesthetics or oxygen.

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2.2) Radiation safety precautions
The user should comply with the laws and regulations of the radiation safety and protection of
the country and region of use.
The device is prohibited to personnel who are not legally qualified to handle X-
ray device.
During exam, use the face guard to minimize the patient’s exposure to
radiation.
While image acquisition is in progress, the user should stay at least 2 m (6
ft) away from the device. For more information on the dose, refer to
“Appendix 2 Dose information.”
Be careful to refrain from going inside the radiation area except for the
patient’s body part that requires diagnosis.
Only qualified users, who finished the special training or were assigned the
job from the product manager, can handle the product.
Without the user's observation of the safe value for exposure and the
correct operation steps, the X-ray device can cause danger to both the user
and the patient.
When using the product, all users should wear radiation prevention device.
Perform exam accurately to prevent additional exams, so that the patient is
not excessively exposed to radiation.

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2.3) Precautions before using
Please check the following precautions before using the Intraoral Sensor.
Use it by following user’s age, gender, body conditions, take care not to exceed the time
required for diagnosis.
Keep checking whether products and patient has problem. If products and patient have
problem, keep the patient safe and stop operating.
Modifications and/or additions to the product must be conducted exclusively
by MANUFACTURER or by parties expressly authorized to do so by
MANUFACTURER. Any modifications or additions must always comply with the
standards and generally recognized rules of good workmanship. And using of
unauthorized parts that cause product malfunctions of the intraoral sensor can
affect product and user's safety.
To ensure the correct usage of the product in a clinical environment, for which
the intended purposes correspond to its design and application, only dentists
or their designated operators are authorized to operate this Product.
The rules of dental radiography apply to digital X-ray systems. Please continue
to use protection for your patients. As a clinician, clear the immediate area
when exposing the sensor.
If your product is recognized as unsafe, immediately stop using it and check
its condition. If any abnormality of the product is confirmed, contact the
manufacturer or the sales company.
Make sure to use a new disposable sanitary cover all the time.
This protection cover complies with the biocompatibility standard ISO
10993-1.
When you remove the sanitary cover on the product, be careful not to
damage it.
For a defective sanitary cover, replace it with a new one and dispose of the
old one.
Wrap the cover around the product as the following picture.

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2.4) Precautions when using
Please check the following precautions before using the product.
The hottest spot at the first 1.5 m part of the cable should not be hotter than 48 ℃.
The capture of the intraoral images should take no longer than 10 minutes.
Intraoral sensor has been determined to be in accordance with international
safety standards and is deemed suitable for use within the patient area. To
comply with these standards, do not operate non-medical device (such as a
PC workstation) inside the patient area. Outside the patient area, the presence
of approved non-medical grade device and Listed /Approved / IEC 60950-1
certified Information Technology Device (ITE) computer device is acceptable.
The operator of this product should abide by applicable regulations of
radiation safety and protection while using it in the patient's mouth. Due to
the rigidity of the product, the patient may need time to adapt.
The capturing positions depend more on the shape inside the patient’s
mouth, the operator's style of practice, and what is needed to be captured,
rather than the position of the teeth.
Use the product following the limitations decided by the external
parameters.
It is recommended for the operator to purchase a separate sensor holder to
fix it, regardless of him/her holding the product with fingers to position the
product to the capturing position inside the patient’s mouth.
Water and other liquids must be kept at a distance to avoid penetration of the
Product. Liquids may cause corrosion or the Product to short circuit. No
protection is offered against liquid penetration.